FDA Approves ‘Revolutionary’ Melanoma Treatment
FDA Wednesday approved drug, Zelboraf, for the first-line treatment of both metastatic and unresectable melanomas, reportedly the most dangerous type of skin cancer. “This has been an important year for patients with late-stage melanoma. Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival,” said Richard Pazdur, M.D., director of […]
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CEL-SCI gets FDA warning letter about web site statements on Multikine
US drug developer CEL-SCI Corp (NYSE AMEX: CVM) says it received a warning letter received from the Division of Drug Advertising Marketing and Compliance (DDMAC) of the US Food and Drug Administration earlier this month regarding certain statements made about the company’s investigational therapy Multikine (leukocyte Interleukin, Injection) on its corporate web site and has […]
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Paladin Labs CEO in serious accident
Paladin Labs Inc.’s chief executive officer has been seriously injured in a cycling accident, raising uncertainty about the company at a crucial time in its history. New Webinar Oct. 12 – Avoid FDA Recall Nightmares – Update from FDA Branch Chief for CDRH Recalls Its shares fell 6% to $38.50 in afternoon trading on the […]
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Merck vaccines contaminated with plastic, says FDA
Vaccines made by Merck & Co at its West Point facility in Philadelphia, US, have been found to be contaminated with pieces of plastic on a dozen occasions since the end of 2009, according to the US FDA. Inspections have shown that pieces of plastic shrink wrap have been discovered in a number of Merck’s […]
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Tobacco giants suing FDA over warning labels mandate
Five tobacco companies, including some of the largest in the United States, filed a lawsuit against the federal government on Tuesday, alleging that government-mandated graphic warning labels on cigarette packages unconstitutionally infringe on the companies’ rights. “The primary complaint is that we think it violates the First Amendment for the government to require people who […]
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Cetero slams FDA on data falsification charge
Early-phase contract research organisation (CRO) Cetero Research has hit back at FDA for representing as pervasive misconduct what Cetero insists was an isolated incident of data falsification at its bioanalytical laboratory in Houston, Texas. New Webinar Oct. 12 – Avoid FDA Recall Nightmares – Update from FDA Branch Chief for CDRH Recalls The US-based CRO […]
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Top Ten Warning Letter Observations about the Pharmaceutical Quality Unit
The responsibilities of the Pharmaceutical Quality Unit are defined in the CGMPs and practices clarified in guidance documents. Just as it is with any legal matter, case histories help us understand how the law is applied in specific situations. That’s the reason it is a good practice to regularly review Warning Letters on the FDA […]
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Some Lessons Learned from 2011 Warning Letters
Earlier this week, we examined the Warning letters that came from FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). Today we’re going to look at a few of the communications lessons learned from same – and reminding us that when in doubt, consult legal and regulatory resources. New Webinar Oct. 12 – Avoid FDA […]
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FDA issues draft guidance on trials for high-risk devices
The US Food and Drug Administration (FDA) has issued draft guidance on the design of pivotal clinical studies to support pre-market approval (PMA) applications for Class III medical devices. New Webinar Oct. 12 – Avoid FDA Recall Nightmares – Update from FDA Branch Chief for CDRH Recalls Class III products are the highest-risk category of […]
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FDA, industry reach generic drug fee agreement
U.S. regulators and generic drugmakers have reached a compromise agreement for a user-fee program that would require the companies to pay some $299 million in the first year to accelerate drug approvals. New Webinar Oct. 12 – Avoid FDA Recall Nightmares – Update from FDA Branch Chief for CDRH Recalls The Food and Drug Administration […]
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